Probe Sought in DePuy ASR Recall Case in India

The Maharashtra Food and Drug Administration (FDA) in India just issued a recommendation that the state home department there submit the case concerning what PharmaBiz described as the inappropriate recall of the DePuy ASR in India to the Central Bureau of Investigation (CBI) for further investigation. More than 4,000 patients have been impacted by the ASR in India.

The recommendation for the CBI probe followed the Mumbai High Court’s (HC) October 14, 2013 order in response to a petition filed by DePuy seeking to quash the state FDA filing (a so-called “FIR”) concerning the alleged inappropriate recall of the DePuy ASR. The FDA filing was made on the grounds that DePuy did not take appropriate measures to advise patients who underwent ASR hip device implant surgery, according to PharmaBiz.

The recall was implemented due to device implant defect and health implications, as well as DePuy’s inadequate compensation for corrective action, PharmaBiz explained. The HC order indicates that DePuy statements were found to be incorrect and it had to withdraw the case regarding quashing the so-called FIR. In India, more than 4,500 DePuy hip implant surgeries were performed from May 2004 to August 2010, prior to the device’s recall, PharmaBiz wrote.

The DePuy ASR recall was announced August 24, 2010 and followed reports of pain in patients due to cobalt and chromium ions release tied to the device. Some 8-9 percent of patients have undergone revision surgery due to device loosening and bone and joint fracture and dislocation, according to PharmaBiz. DePuy documents submitted to the state FDA revealed that of 280 patients, 68 underwent revision surgery (25 percent). Of the 68 patients, 63 allegedly suffered from pain; 10 suffered from a number of painful conditions including difficulty ambulation, device loosening, and the inability to bear weight.

The Maharashtra FDA initiated the probe following DePuy ASR recalls in the United States, the United Kingdom, and Australia and also filed the FIR against DePuy based on an anonymous complaint and that the device maker did not appropriately act, despite a number of FDA letters in 2011. Among other actions, and due to its violation of the Indian Penal Code and sections of the Drugs and Cosmetics Act 1940 and Rules 1945, and in response to the inappropriate recall, the Drugs Controller General of India (DCGI) canceled DuPuy’s import license and registration certificate. According to Madhuri Pawar, assistant commissioner, Maharashtra State FDA, “Patients who had undergone the hip replacement surgery using ASR implants and are suffering because of related symptoms can approach the State FDA headquarters or concerned police station for further guidance regarding compensation,” PharmaBiz reported.

In the United States, Johnson & Johnson recently settled another one of the nearly 11,000 lawsuits it faces over the ASR, court records indicate. Last month, Johnson & Johnson agreed to settle a bellwether case that was part of a multidistrict litigation (MDL) organized in California state court. Other legal action includes an MDL in New Jersey’s Bergen County Superior Court and in U.S. District Court, Northern District of Ohio. Meanwhile, DePuy sold another metal-on-metal implant under the Pinnacle brand, which is the focus of litigation, including an MDL in the U.S. District Court for the Northern District of Texas.